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TOPIC: Bioworld Article Says Cytori Has Approval for Knee OA in Japan

Bioworld Article Says Cytori Has Approval for Knee OA in Japan 23 Mar 2018 13:02 #11593

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Quote from article in Bioworld about Athersys and Healios regarding ne Japan Regmed Laws:

" So far, it has approved two products: the adipose-derived Cytori Cell Therapy for knee osteoarthritis and remestemcel-L, a therapy developed by Mesoblast Ltd. with JCR Pharmaceuticals Co. Ltd. for the treatment of acute graft-vs.-host disease."

www.dropbox.com/s/hcbi9vwlvmr8cru/2018-03-21%20BioWorld%20Today.pdf?dl=0

What's up with that?
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Bioworld Article Says Cytori Has Approval for Knee OA in Japan 24 Mar 2018 05:38 #11596

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It is truly strange. However when you take into account the following announcement:
''Congratulations to Sobajima Clinic on milestone: 100th knee #osteoarthritis patient treated with Cytori Cell Therapy, facilitated by Japan’s new Regenerative Medicine Law $CYTX'' hen i all falls ino place.

I am assuming that CYTX has received approval for use of SVF Celution device for OA, hence the above.

To not issue a formal statement of such a material event but to disclose it cryptically through a vague tweet is .................:KO: :bash: :evil: :puke:

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Bioworld Article Says Cytori Has Approval for Knee OA in Japan 24 Mar 2018 11:15 #11597

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rongside wrote: It is truly strange. However when you take into account the following announcement:
''Congratulations to Sobajima Clinic on milestone: 100th knee #osteoarthritis patient treated with Cytori Cell Therapy, facilitated by Japan’s new Regenerative Medicine Law $CYTX'' hen i all falls ino place.

I am assuming that CYTX has received approval for use of SVF Celution device for OA, hence the above.

To not issue a formal statement of such a material event but to disclose it cryptically through a vague tweet is .................:KO: :bash: :evil: :puke:


I had a similar conversation with DOV over email TWO YEARS AGO after I believe, what was an Cytori IR tweet (not sure anymore) on the same subject.

One might remember that Celution already received Class I device approval 3-4 years ago in Japan and with the new regenerative law they have two regulatory options/pathways- i.e. the drug route - ANDRESU as the example. Or device- here patients are treated at SPECIFIC clinics, which after having proven that they can effectively treat the condition receive SPECIFIC clinic approval (elective- not reimbursed)

Last year there were already 6-7 clinics with OA approval- as far as I know that number is expanding and also the apps.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Bioworld Article Says Cytori Has Approval for Knee OA in Japan 24 Mar 2018 16:44 #11598

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Fas wrote: Or device- here patients are treated at SPECIFIC clinics, which after having proven that they can effectively treat the condition receive SPECIFIC clinic approval (elective- not reimbursed)

The words ''effectively treat'' are key. While I understand that the OA treatments using SVF are not reimbursed at this stage I would assume that the health authorities would at some point wish to evaluate the TRUE effectiveness of this treament paradigm. Expanding the number of licensed clinics undertaking OA procedures is not rational unless there is substantial proof of efficacy! What is going on?. What are we not being told? I cannot believe that the Japanese have not put in place a mechanism to evaluate on an ''ex post'' basis the effectiveness of the therapy. In fact, I believe that it is required by law.

Nor can I believe that there is no genuine interest in this technology or company. Any normal management would have done a deal years ago (or successfully developed he technology). Why are they holding out? What is management's end game?:KO:

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Bioworld Article Says Cytori Has Approval for Knee OA in Japan 24 Mar 2018 17:40 #11599

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Without reimbursement OA Knee approval does not mean much as can be seen by the anemic sales level. Cytori already failed to show efficacy in their U.S.trial. Without a placebo control, you can't prove it works. Pain is a funny thing and often not related to any physical ailment.

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Bioworld Article Says Cytori Has Approval for Knee OA in Japan 24 Mar 2018 19:48 #11600

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Even with reimbursement, in Japan, the patient still must pay 35% out of pocket.

Q4 sales...usually a strong quarter saw world product sales of approx. 600K and change.
WAKE UP !!!
No one is using our product. Margins stink. All they can do is throw out fluff like the 100th knee treated. Consumables up 23% (or what ever it was).
The numbers are miniscule and they can still barely grow them...in fact sales were DOWN 50% YoY.

All we are waiting for is to see if Hedrick can get another,
getyarn.io/yarn-clip/bf685bd8-fbbc-4781-b5c0-a180659da2fa

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Bioworld Article Says Cytori Has Approval for Knee OA in Japan 25 Mar 2018 00:50 #11601

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My bad .........:whistle: .......... CYTX did in fact provide notification of Japanese approval:

ir.cytori.com/investor-relations/news/news-details/2016/Cytori-Cell-Therapy-Receives-Limited-Approval-for-Osteoarthritis-in-Japan/default.aspx

We, and obviously the market have not truly understood that we ARE approved to treat OA commercially, and not as part of some trial. This raises a whole host of questions as per WST remark, What's up with that?

As per Fas: Last year there were already 6-7 clinics with OA approval- as far as I know that number is expanding and also the apps.

The fact that there may well have been hundreds of OA operations given the above raises a lot of questions.

1. What is the price at which we sell the consumables.
2. What is the gross margin that this provides on COGS
3. How many Celution units are in place
4. Why has the number of units sold fallen in the last quarter/year? Is it a client demand issue or company issue?.
5. Is there any provision for review of patient outcomes to determine continuation of treatment access and/or possible reimbursemen?

I would assume that a serious ramp up in utilisation is based on trial data vis a vis placebo. Only then will reimbursement be possible. Having said that I find it difficult to believe that the Japanese would not have some sort of efficacy assesment protocol in place. Is CYTX pricing the consumables low in order to get a large sample of treated patients?, or do they have to undertake blinded trials?

A couple of points that raise other questions. (1) While it is true that Japanese patients normally have to pay 35% of the cost of funded treatments we are seeing a number of patients who are quite happy to pay 100% of the cost. Paying 100% of cost for much more dubious procedures has not deterred thousands of US citizens from attempting regenerative medicine procedures.
(2) Uptake of an unvalidated (as yet) treament is quite likely to deter many, and we should also note that this is an application that is at the very beginning of its product life cycle.

Has anyone considered what the consequences would be for all the allogeneic providers of stem cell therapy in the face of a low cost autologous treament option? What would be the effect on knee implant companies such as Stryker, Smih & Nephew, Biomet, Depuy, Zimmer etc.

Someone please explain to me how none of the above companies are not potential buyers of CYTX. Even if only as insurance in case the technology actually works, the price of CYTX is dirt cheap, irrationally so ............. unless there really is a conspiracy.:puke:

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Bioworld Article Says Cytori Has Approval for Knee OA in Japan 25 Mar 2018 10:05 #11602

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Although the slides below cannot give answers to all questions raised- quite a few can be answered with them.

It is clear that overall and Hedge will inform you every day- Japanese revenue has been on the re-treat. To me it is clear why- no installs, which used to be the big money in the past (and not the disposables). The strategy going forward with CTX2 is totally unclear.

Anyway for those who have not followed cytori for a while there is a lot of information below-





Attachments:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Bioworld Article Says Cytori Has Approval for Knee OA in Japan 25 Mar 2018 12:03 #11603

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The big problem here is approval without insurance reimbursement isn't worth much. I know that when I first corresponded with Marc years ago when the new regmed law was being discussed, he wasn't on top of it. Gil Van Bokkelen told me that conditional approval would include reimbursement. Marc kind of laughed that off as unrealistic. Whether the difference is related to an autologous medical device vs. an off-the- shelf allogeneic therapy, I am not certain. But here we are years later and Gil has a partnership in Japan and a fully paid for stroke clinical trial that only needs to show safety and some evidence of efficacy to get the cash spigots going. Full approval would be an added bonus. Furthermore, the recent commitment by Healios greatly strengthens Athersys position overall and illustrates how confident the scientists at Healios are with MultiStem. If Marc had been CEO of Athersys back then, the company would never be in its current strong position, IMHO. If anyone should be on top of regulatory developments in regenerative medicine it should be the CEO of a stem cell company and his large staff. Maybe with different decisions based on understanding the new law they would be getting reimbursed for OA today although I still believe the autologous model is a huge disadvantage..

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Bioworld Article Says Cytori Has Approval for Knee OA in Japan 25 Mar 2018 20:14 #11604

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***It is clear that overall and Hedge will inform you every day- Japanese revenue has been on the re-treat.***
Well, not EVERY day :grin:

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Bioworld Article Says Cytori Has Approval for Knee OA in Japan 26 Mar 2018 08:11 #11605

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WST, there is no doubt that ATHX is in an advantageous position. The target selected ie. stroke is a compelling one and that it is very rational for Healios to partner multistem as it is certain that health providers will reimburse treatment lucratively given the societal cost of stroke care and rehabilitation (if lucky).

Scleroderma is neither as big a market opportunity nor as compelling. Having said that, if it can be shown that autologous ADRC are effective, the range of conditions potenially treated is huge & compelling.

As per the Japanese regenerative medicine legislation:

The 7 Year Conditional Approval Period
The intent of the laws is to accelerate the commercialization of cell therapeutics within Japan by allowing companies to benefit from conditional marketing authorization.

Therefore, cell therapies that show safety and probable efficacy during Phase I and Phase II trials can get conditional approval for up to seven years, during which time:

1) Larger-scale, later-stage clinical trials are performed
2) Revenue from the cell therapy is pursued within the Japanese market

During the seven-year conditional approval period, companies must continue to submit clinical trial data to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and subsequently apply for final marketing approval or withdraw the product within seven years.


Two simple questions for management: (1) What efficacy data are you collecing, (2) are additional trials required in Japan to get reimbursement or is the follow up daat sufficient , if posiive?

Obviously there are follow up questions. I do not see how it is possible for CYTX to run larger trials in Japan withou a partnership deal. I would assume that the accumulating data for patienst with OA should be sufficient from both a volume and duration perspective for potenial parners to assess ADRC/Celutions prospects.

I believe a large Japanese pharma should/could be interested for a Japanese license to treat ALL indications. We shall see.

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